WELLBORNE PHARMACHEM & BIOLOGICALS

Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
1 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Product: Batch No.

Prepared By P.O.:
Approved By:
Checked By Q.A.: Prod. Manager
Q.A. Manager
Batch Size

Date Commenced Date Completed Supervised By:

PRODUCT DESCRIPTION

Glass Vial cc Seal Color ( )

Presentation (Sale) 1’S

Presentation (P/S) 1’S

Instructions:

a) All documents must be completely and clearly filled in, signed & dated by the concerned
personnel.
b) Any correction(s) or changes must be initialed and dated. Overwriting and Use of
Blanco / whitener is prohibited.
c) Any observation(s) or suggestion(s) at any stage must be written overleaf.
d) All the relevant documents (s) associated with the production of the batch should be
attached with this BMR.
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
2 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 1. Pre – Washing GMP Checks

Area cleaning and status checks

 Before starting washing ensure that:

 Washing area is clean & clear from the remains of previous product.

Previous Product: -------------------- Batch No. ------------------)

 Related documents of the product to be are properly filled and available.

 Quantities of the glass vials, rubber stopper and aluminum seal have been checked to be
correct as per Packing Order.
 Air conditioning system is working properly .

 Labels on glass vials, rubber stoppers and aluminum seals to be washed have been checked
for correct material and lot no.

Production Officer Date

Equipment / Machine cleaning & status check

 Equipment / Machine (washing machine, SS trays, filters, sink etc.) to be used for
washing are, clean and clear from the remains of previous product.

Previous Product: --------------------) Batch No. ------------------)

 In the water storage tank temperature should not below (70 C 0 to 80 Co) and pressure should
not be less than 20 psi.

Production Officer Date

 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
3 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 2. Washing of Glass Vials, Rubber Stoppers, Aluminum Seal

Glass vials Date Operator Supervised

By
 On receiving the packing order the vials
decartoned in the decartoning room and load in
the SS trays.
 Turn On LFH at least 15 minutes before start of
washing.
 Wash the vials with distilled water and the
temperature of thedistilled water should be
70 Co and pressure should not be
less than 20 psi.
 Load the glass vials invertly in the washed SS
trays.
 Perform all the activity under the laminar flow.
 Pressure and temperature in different intervals
1. Pressure _______________psi.

Temperature________________oC
Time______________________

2. Pressure _______________psi.

Temperature________________oC
Time______________________

Washing Start Time Washing Complete Time Total Time

Total Number of vials rejected during

Washing
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
4 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Date Operator Supervised

Rubber Stoppers Washing By
 Take about 5 liters of distilled water in a SS bucket
and add 50 g of sodium pyrophosphate.
 After about half an hour, when the salt is
completely dissolved, soak the rubber stoppers in
this solutions and leave for half an hour .
 Rinse the stoppers with distilled water 2---3 times
and ensure that there are no more traces of
Sodium pyrophosphate.
 Put the washed rubber stoppers in a SS container
and wrap in aluminum foil.

Ref SOP No WB/PR/SOP/081

(washing of Glass Vials Rubber Stopper and seal )

Total no of rubber stopper washed---------------------------

Washing Start Time Washing CompleteTime Total Time

Total Number of Stoppers rejected during

Washing.

Flipp off Seals Washing Date Operator Supervised

By
 Take aluminum seals in SS bucket, rinse
thoroughly with distilled water pack in SS
container and wrap in aluminum foil.

(washing of Glass Vials Rubber Stopper and seal )

Total no of Tear off seal washed

Washing Start Time Washing CompleteTime Total Time

Total Number of seals rejected during

Washing
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
5 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 3. Sterilization of vials Date Operator Supervised

By
 Before starting the sterilization wash the dryer is
from inner and outer side thoroughly with distilled
water using lint free duster.
 Mope the dryer with IPA (70 %) internally.
 Wash the trolleys with distilled water and clean
with IPA (70 %).
 Check the equipment for proper cleaning.
 Load the trays containing washed vials into the
trolleys.

 Program the timer and attach the graph paper

on it.
 Set the temperature controller to the 220 C o
 Maintain the temperature of two and half hours for cycle
completion.
 Turn the dryer ”OFF” after two and half hour by
noting the time and temperature on the graph.
 Disconnect the “POWER SUPPLY” and leave the
vials in the dryer to be cooled down to
the room temperature.

(Sterilization of vials)

(Operation of dry heat Sterilizer )

Machine parts if any sterilize

Total no of vials Sterilize

Sterilization cycle Sterilization cycle Total Time

Start Time Complete Time
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
6 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 4 Autoclavation (steam sterilization) Date Operator Supervised

By
 Before starting the sterilization wash the autoclave
from inner and outer side thoroughly with distilled
water using lint free duster.
 Mope the chamber of Autoclave with IPA
(70 %) internally.
 Wash the trolleys with distilled water and clean
with IPA (70 %).
 Check the equipment for the proper cleaning.
 Load the containers containing washed rubber
stoppers, aluminum seals and uniforms.

 Turn “ON” the power of autoclave.

 Program the timer and attach the graph paper on
it.
 Open the “Steam Valve” and note the pressure
(The pressure must not be less than 1kg/cm2and
not more than 1.5kg/cm).
 Maintain the pressure for half hour to complete the
sterilization time.
 Shut down the steam and autoclave.

Time------------------- Pressure
Total number of rubber stopper and tear off seal sterilized
Total number of gloves sterilized
Machine parts if any sterilized--------------------

Autoclavation cycle Autoclavation cycle Total Time

Start Time Stop Time
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
7 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 4.1 Drying Of Seals /Rubber stopper Date Operator Supervised

By
 From inside the sterile area transfer the rubber stopper and
seals to dry heat sterilizer for drying cycle
 Set the temperature controller to 130 C
 Maintain the temperature for 3-4 hrs for cycle completion
 Turn the dryer OFF after3-4 hrs by noting the time
and temperature on the graph.
Drying start DRYING Total Time
Start time stop Time

Step 5. Sterilization of active through UV lights Date Operator Supervised

By
 Thoroughly clean the containers with IPA .
 Expose the raw material under the high intensity UV light for over /
more than 12 hours.
 Ensure that the door of the pass through is properly closed.
 Total number of container--------------------

Material Exposed Material Exposed Total Time

Start time Complete Time

Step 6. Pre –Filling GMP checks

Area cleaning and status checks
 Prior to the start of the work ensure that the vials filling are and equipment are clean and area
report from the Q.C is satisfactory. Relative humidity should not exceed 45 % and temperature
not be more than 25 Co throughout the filling process.
 Before entering into the sterile area make sure that the UV lights have been switched off.
 Personnel working in the sterile area must wear the designated sterile area uniform.
 Personnel entering into the sterile area must posses sound health, and should sign health
Performa. They should not be suffering from common cold and any other respiratory infection,
Bronchitis, sore throat, skin infections rashes open wounds or skin abrasions, eye infections
diarrhea or stomach upset.

Production Officer Date

 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
8 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 7. Sterile Area Monitoring Report

Date:______________ Monitored By:________________

Sampling Status: __________________ Checked By:_________________

Method: __________________________

No. Critical Cite Exposure Limit Result

Powder Filling Room
A Laminar Flow hood (Horizontal) Nil CFU
B Laminar Flow Hood Nil CFU
C Under HEPA Filters (Vertical) Nil CFU
Vials Sealing Room
D Under HEPA Filters Nil CFU
E Center of the Room 01 CFU
F Autoclave/Dry heat sterilizer 02 CFU

G Pass Through Nil CFU

H Change Room 02 CFU
Remarks
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
9 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Microbiologist A.Q.C. M/QCM A.Q.A. M/Q.A.M

Step 8. Vials Filling Date Operator Supervised

By
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
10 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

 Before starting the operation clean the filling

machine with moist lint free duster. Duster
should be moistened with IPA 70%.
 Check the positive pressure in the following area
 Filling Room Std._NLT 0.180 Inches of water
Actual_________
 Sealing Room Std._ NLT 0.130 Inches of water
Actual_________
 Change Room Std._ NLT 0.080 Inches of water
Actual_________

 Calibrate the electronic balance with standard

weight and record.
 Load the empty vials in the turn table.
 Dispense Hydrocortisone according to MO and
put it in machine hopper as per requirement.
 Start the filing machine and adjust the
weights according to the pre define standard.
 Weigh the contents of 5 vials and record on
the log sheet.
 Send minimum of 5 vial to the Q.C for weight
variation check.
 After taking the report from Q.C. , start filling
and check weights after regular interval of 30
minutes.
 Adjust the sealing machine according to the
size of vials and seals, (Vials 10cc, Al. Seal,).
 Seal 20 to 30 vials and check the sealing.
 Send at least 05 vials to Q.C for sealing quality
check.

Filling Start Time Filling Complete Time Total Time

 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 9. Inprocess Control Form (Vials filling)

Product: ______________________ Upper weight limit.: __________________

Batch No: ____________________________
B. Size:
Machine: Vials Filling Objective fill weight __________________
Operator: ____________________________
Supervised By: _______________________ lower weight limit.: __________________

Date Time 1 2 3 4 5 Checked By Temp. RH Checked By

Rejection During Filling

Glass Vials __________________________

Seals _______________________________

Stoppers ____________________________
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
12 of 23
Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Step 10. Analytical Report (Filled Vials)

Send request for analysis to Quality Control Department for Date Operator Supervised
Physical & Chemical and Microbiological (Sterility and BET) By
testing of Vials wait till results received from Quality Control
Department.

Sampled By: ______________ Date: _______________

Parameter Specifications Result Remarks

White to pale buff
crystalline powder in clear
Description glass vials having grey
rubber stopper with yellow
flip off seal

Reconstituted Clear transparent solution

Solution usually free from foreign
particles

Moisture NMT 5%

PH 4.5 – 6.5

Assay 90 – 110 %

Should pass the test

Sterility for sterility

Becterial
Endotoxin Should pass the test
Test for BET/pyrogen
(BET)/pyrogen
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Analyst/Microbiologist A.Q.C. M/Q.C.M A.Q.A. M/Q.A.M

Step 11. Exposure of Media Plates After Filling to Date Operator Supervised
Monitor the Area By
 Expose the Media plates after filling in the filling room
sealing room pass through and change room for half an
hour.
Before the media plates are exposed these are kept under UV
lights in the pass through for half an hour

Media Plate Exposure Media Plate Exposure Total Time

Start Time Stop Time

Step 12. Cleaning, Mopping and Fumigation of Date Operator Supervised

the Sterile Area By
 Mop the whole Sterile Area except filling and change room
with disinfectant solution. The disinfectant solution are 70%
IPA or 5% Phenol solution alternatively.
 Clean the filling machine and sealing machine with 70 %
IPA..
 Fumigate the filling and sealing area by the preparation of
the fumigation solutions, Take about 1 to 2 gram of KmnO4
in the petridish and add about 10 ml of formalin solution.

Cleaning Start Time Cleaning Stop Time Total Time

Step 13. Vials Optical Checking Date Operator Supervised

By
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

 Total number of vials produced after filling______________

 Number of vials rejected during optical checking _________

 Total No. of vials produced after the optical checking ____

_______________________________________________

Optical Checking Optical Checking Total Time

Start Time Complete Time

PACKAGING
Step 14. Over Printing Record

Product (Sales) Over-Printing (Sales)

Product: Matter to be Printed
Item: Labels /Cartons Batch No.:
Mfg. Date:
Quantity: Exp. Date:
Packing Officer: M.R.P.Rs.: Label Carton
Printing Checked By: P. Officer. QAI.

Date Item Qty. Issued Printed Checked By Qty. Acceptable Print Reject Qty. Prod.
By By
Cartons
(Sale)
Label
(sale)
Cartons
(P/S)
Label
(P/S)
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Sample’s Cartons & label (Sale)/P/S / attached back side of the paper.

acking Officer Q.A. Inspector Date

Step 15. Pre-Packaging GMP Checks

Area cleaning and status check

 Before starting Packaging ensure that :
 The packaging area is clean and cleared from the remains of previous products.

Previous Product: --------------------) Batch No. ------------------)

Packing Officer Line Clearance by QAI.

 Product to be packed is properly identified and approval has been taken from the Quality
Assurance Department.
 Conveyer belt is clean and cleared from the remains of previous product.
 All packaging components have been verified and cross checked as per the quantity mentioned
in the packing order.
 Related documents of the product to be packed are available on the belt.
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Packing Officer QA Inspector Date

Equipment / Machine cleaning & status check

 All equipment required for packing i.e. Conveyer Belts, are clean and cleared from the remains
of previous product

Previous Product: --------------------------- Batch No.: -------------------------------------)

Ref. SOP No. CP/PR/SOP/091) (Cleaning of conveyer belt)

Packing Officer Q.A. Inspector Date

Step 16. Handing Over Date Delivered By Received By

Vials Delivered Vials Received Name & Name &
# # Sign. Sign.

Step 17. Line Control Sheet (Sales)

Product Over-Printing
Product: Product :
Packing: Sale Batch No.:
Batch No.: Mfg. Date:
Belt Incharge: Exp. Date:
P.O. Available: Yes No M.R.P.Rs.: label Carton
Equipment / Operation clearance
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Previous Product:
Clearance Granted
Batch No.:
Ensure that there should not be any remains Production Officer Time Date
Of the previous batch.
Checked by Belt Incharge:
Quality Assurance Time Date
Production Officer: Inspector
Online Inspection
Date Time Over General Appearance WFI Leaflet Pack QAI P.O
Printing Cartons Labels Size

Step 18. Reconciliation Sheet (sale)

Product: ____________________. (Sales)

Batch No.: ___________________________ Batch Size: __________________________
Presentation: 1’ S
S.# Items Units Quantity Rejected Allowable Qty.
Received Used Unit % age Wastage Returned
1. R. Stoppers No. 5%

2. Tear offSeal No. 10%

3. Glass vials No. 8%

4. Labels No. 3%
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

5. Cartons No. 2%

6. Leaflets No. 1%

7. WFI 5 ml No. 1%

8. Shippers No. 1%

9.
10.
11.

Remarks
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________
____________

Packing Officer Q.A. Inspector D.M. Pr / Pr. Manager Date

Step 19. Disposal / Destruction of Excess / Rejected Material (Sale)

Product: ____________________________
Batch No.: ___________________________ Batch Size: __________________________
Presentation: 1’s
S.# Items Rejected % age
Unit Quantity
1. Rubber Stoppers No.
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

2. Al-Seal No.

3. Glass vials No.

4. Labels No.

5. Cartons No.

6. Leaflets No.

7. WFI glass (5ml) No.

8. Shippers No.

Packing Officer QAI D.M. Pr / Pr. Manager Date

Step 20. Yield Statement

Product: Mfg. Started:

Batch No.: Mfg. Completed:
Batch Size: Packing Started:
Presentation Sales 1’s Packing Completed:

Manufacturing
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Powder Dispense Reworking Left Variance (C) Remarks

(A) (B) (A-B) (Kg)

Objective Fill Weight of Vials (D):____________________________________________________

Optical Checking

Vials Reject During the Optical Checking In-process QC Samples QC Sample for Sterility & Chemical
(E) (F) Analysis (G)

Packing (Sales)
Total Qty. Packed In-process QC Sample Total Unit
(H) (I) (H+I)

Partial transfer, if any (Sales): ______________________________________________________

Net unit transferred to the FGWH sales (H-I): __________________________________________

Net unit transferred to the FGWH sales (J-K): __________________________________________

Sales

Theoretical M = C x 1000 x 1000

Yield Objective Fill Weight (D)

Actual yield N = (H+I) x 100

L
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Production Officer Packing Officer Prod. Manager

Step 21. Analytical Report (Final Product)

Send request for analysis to Quality Assurance Department Date Operator Supervised
and ask for sampling of Final Product. By

Sampled By: ____________________ Date: _______________

Parameter Specifications Results Remarks

Filled labeled packed

Description clear glass vial having
flipp seal.
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

B. #.
Mfg. Date
Printing Exp. Date.
M.R.P.Rs.
as per BMR

Pack Size 1’s (Sale)

1’s (PS)

WFI,leaflet powder
Insert vial .

Q.A. Inspector Q.A. Manager

Finished Product Transfer Slip

Product Name: __________________ Batch #._____________

Date Time Pack size Qty. Transferred Total Qty Status Issued By Recvd By
No.of M/C Loose Pack Transferred
Till Date
 WELLBORNE PHARMACHEM & BIOLOGICALS
Document Number
CP/PR/QR/175
BATCH MANUFACTURING RECORD Revision Number
00
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Written By: Production Manager Reviewed By: Q.C. Manager Q.A.Manager

Batch Size:_______________ Mfg Date :___________ Exp Date:___________

Total Quantity transferred on Completion of Batch:____________________

Pack Size:_______________ _____________________________

Sample to Q.C __________ ______________________________

Total Batch Qty:__________________ ______________________________